Sauna Detoxification Study: Pilot Feasibility

According to our nationwide survey of Naturopathic Physicians regarding use of
detoxification, approximately 80 percent of NDs use some type of detoxification
interventions in clinical practice on a regular basis. Of the interventions used, 66% of
respondents reported using sauna therapy. Of the conditions treated, over 80 percent of
practitioners use sauna-based detoxification for "general cleansing/preventive medicine."
This protocol will utilize a sauna as the primary method of detoxification.

Previous studies on hyperthermia-based protocols for detoxification have been
methodologically challenged and are not readily reproducible. Furthermore, there are no
studies in the literature that identify how long of a protocol is tolerated, is feasible in
the general population, or how long is needed to observe PCB (or other pollutant reduction).
Therefore, we will employ a "high-dose" protocol and a "low-dose" protocol, based on ranges
reported in the literature, in order to evaluate dose-finding outcomes to hyperthermia,
including tolerability, retention, and participant-reported outcomes.

High Dose Participants randomized to this group will undergo a protocol consisting of 2
hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or
less (21 days). (15 total sessions, 30 hours of sauna). Participants will be able to
schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as
well as flexibility in which days are attended will be utilized to increase likelihood of
retention. A participant may attend visits for 15 consecutive days, should they wish.

Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour
of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21
days). (9 total sessions, 9 hours of sauna). Participants will be able to schedule visits on
any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in
which days are attended will be utilized to increase likelihood of retention. Participants
will be able to attend 9 consecutive sessions, should they wish.

Inclusion Criteria:

1. 21-35 years.

2. Body mass index (BMI) 19 to 30 kg/m2 at the screening evaluation.

3. Ability to schedule and attend daily visits for the duration of the study.

4. If female, willingness to use barrier contraception (e.g., cervical cap, diaphragm,
condom, metal IUD (non- hormone)) throughout the study and take a pregnancy test at
screening, and weekly during the study.

Exclusion Criteria:

1. Pregnant, or trying to become pregnant in the three months following screening.

2. Current use of any prescribed pharmaceutical medications (including oral
contraceptive pills, without additional barrier contraception).

3. Participants who have a BMI greater than 30 kg/m2, elevated fasting blood sugar,
bradycardia, hyper or hypotension or evidence of a medical condition.

4. A diagnosis of any chronic medical condition (e.g., multiple sclerosis, diabetes, or
endocrine disorders, liver disease, kidney disease, HIV/AIDS, or cancer, or with a
reported history of substance abuse or mental illness within the past 5 years, or a
mental health disorder in the past 6 months.

5. Clinical chemistry lab values outside of reference lab normal ranges (except in cases
of ranges within 10% ULN and isolated measurements in the absence of chronic
disease).

6. Recent infection (<14 days), open sores, or communicable skin conditions.

7. Current use of any tobacco products or illicit drugs.

8. Any condition that in the opinion of the investigators or IRB would preclude the safe
completion of the study (e.g., clinical or mental health concerns that arise from the
screening questionnaire or physical exam).